Batch Record Review
We review batch records for completeness, accuracy, and CGMP compliance — helping prevent release delays caused by documentation gaps.
Quality Assurance & Control
Better continuity for manufacturing
and product quality.
We help pharmaceutical manufacturers overcome business disruptions tied to manufacturing or product quality — from batch disposition and investigations to method validation and environmental monitoring.
02
Service
detail
Quality problems slow everything down — production, release, trust.
A single unresolved deviation or an incomplete batch record can hold up release, delay shipment, and put a facility's reputation at risk. We work alongside your team to keep manufacturing and quality operations moving, while making sure the underlying systems can support that pace long-term.
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What we help with
Targeted support for
manufacturing continuity.
Focused support for product disposition, operational quality systems, and manufacturing continuity.
- Batch record review
- Investigations & CAPA
- Technology transfer & method validation
- Stability programs
- Aseptic processing validation & environmental monitoring
Service breakdown
Seven areas of QA/QC support.
Investigations & CAPA
We support root-cause investigations and help design CAPA plans that are technically sound, realistic to implement, and defensible during inspection.
Technology Transfer
We help manage the quality and documentation side of moving a product or process between sites or manufacturers, keeping validation and compliance intact throughout.
Method Validation
We support the validation of analytical and manufacturing methods, ensuring they meet regulatory expectations and hold up under scrutiny.
Stability Programs
We help design and review stability programs that generate reliable data to support shelf-life claims and regulatory filings.
Aseptic Processing Validation
For sterile manufacturers, we support the validation of aseptic processes — a critical, high-scrutiny area during FDA inspections.
Environmental Monitoring
We help build and evaluate environmental monitoring programs appropriate to your facility's classification and risk profile.
Who this is for
Support built around your
manufacturing reality.
Whether you're managing a single manufacturing line or a multi-site operation, our quality assurance support scales to sterile injectable, ophthalmic and otic, oral dosage, and transdermal/transmucosal manufacturing — across branded, generic, OTC, and compounded drug production.
Talk to an expertHow we work
A structured path to
manufacturing continuity.
The same four-step engagement path used across Steripharm services, contextualized to QA/QC.
- 01
Frame
We understand the quality challenge affecting your manufacturing or release timeline.
- 02
Focus
We prioritize the systems, records, and risks driving the disruption.
- 03
Act
We support the investigation, validation, or review work directly — hands-on, not just advisory.
- 04
Embed
We help build the practice into your standard operations, so quality and speed stop competing.
FAQ
Quality assurance & control — common questions.
What manufacturers ask most about batch review, CAPA, and validation support.
Ask a different questionCan you review batch records for a single release, or only ongoing programs?
Both. We support one-off batch record reviews as well as ongoing quality assurance programs.
Do you help write CAPA plans, or just review existing ones?
Both — we can lead root-cause investigations and CAPA development from the start, or review and strengthen a plan already in progress.
Do you support aseptic processing validation for sterile manufacturers specifically?
Yes. Aseptic processing validation is one of our core areas of QA/QC support for sterile injectable manufacturers.
Can you assist during a technology transfer between two manufacturing sites?
Yes. We support the quality and documentation side of technology transfer to help keep validation and compliance intact through the move.
Related services
Explore the rest of our capabilities.
Inspection-ready systems, made practical.
Support for Form 483 and Warning Letter responses, remediation plans, mock pre-approval audits, vendor audits, due diligence, and regulatory submissions review.
Explore FDA ComplianceTwo focused service tracks for FDA-regulated manufacturers.
See how FDA compliance and quality assurance work together across the full Steripharm service offering.
View all servicesStart with clarity
Build sustainable compliance into every next step.
Talk with Steripharm Solutions about your quality assurance objective.
